In HIV-NAT 013 phase I study, genotyping was performed in 95 children on dual NRTI which showed that almost all children had resistance to NRTi. The HIV-NAT 013 phase II is a follow up study to evaluate treatment outcome after salvage therapy and the evolution of mutations.

Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:

Clinical, immunologic and virologic outcome of children who had genotyping directed salvage therapy [ Time Frame: 1 time point (Cross Sectional Study) ]

Secondary Outcome Measures:

Comparison outcome of children in the 3 groups, [ Time Frame: 1 time point ]

Changes of mutation in children within the 3 groups, and [ Time Frame: 1 time point ]

Effect of previously unreported mutations, minor and others, on treatment outcome [ Time Frame: 1 time point ]

Enrollment:

95

Study Start Date:

January 2006

Study Completion Date:

April 2009

Primary Completion Date:

April 2009 (Final data collection date for primary outcome measure)

Detailed Description:

The HIV-NAT 013 study (conducted in 2003) evaluated prevalence and pattern of RT mutation in 95 children treated with dual NRTI. The study showed almost all children to have some degree of NRTI resistance and 40% with multi NRTI resistance. The mutation reported was major mutation.

After the study, the patients were managed based on the physician's judgment using genotyping results. The 95 patients in HIV-NAT 013 are categorized into 3 groups.

No viral resistance

Low grade resistance with or without clinical/ immunological failure

High grade resistance with or without clinical/ immunological failure.

There are also new mutations that are not considered major mutation that may affect treatment outcome

Knowledge learned from this study will benefit Thai children with NRTI resistance by helping pediatricians better choose salvage treatment options

Eligibility

Ages Eligible for Study:

1 Year to 18 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

All children from HIV-NAT 013 phase I

Exclusion Criteria:

No inform consent obtained

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477308